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Completed

NCT Number: NCT06119399

Diaphragmatic Doming vs Breathing Exercises on Ventilatory Function & Core Endurance in Chronic Neck Pain

The purpose of the study is to investigate if there is any difference between effect of diaphragmatic doming versus breathing exercises on ventilatory function and core endurance in patients with chronic neck pain

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic; Faculty of Physical Therapy, Badr University in Cairo., Cairo, Badr, Egypt

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About this study

Patients with chronic neck pain will be participated in this comparative study.

They will be divided into 2 groups:

Group (A) will be consisted of 30 patients who will receive conventional physiotherapy treatment for chronic neck pain plus breathing exercise (diaphragmatic and pursed lip breathing) (Three sessions per week for 6 weeks) Group (B) will be consisted of 30 patients who will receive conventional physiotherapy treatment for chronic neck pain plus Doming of the diaphragm (Three sessions per week for 6 weeks)

Pulmonary functions and neck endurance will be assessed for all patients in both groups before the first session and after the last session

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has chronic neck pain (for more than 3 months)
  • Their age ranged from 20 to 30 years old
  • Their body mass index ranged from (18.5 -29.9) kg/m2
  • Poor results on the cranio-cervical flexion (CCF) test using a pressure biofeedback instrument.

Exclusion criteria

  • History of respiratory disease and Clinical signs of a severe cardiac event.
  • Severe psychiatric or cognitive impairment
  • Tumor and Spinal fractures
  • Spinal cord compression that required urgent surgery
  • Current or past Smokers
  • Obese (BMI >30) or underweight (BMI ˂18.5)

Treatment and study plan

Diaphragmatic breathing exercise

Other

Diaphragmatic breathing exercise will be taught by placing the subject comfortably positioned with either therapist or the patient's hand directed over the abdominal area and instructing the subjects to focus on an outward movement of the abdominal area throughout inspiration and an inward movement of the abdominal area during expiration. (4 sets, and as each set had 4 complete breathing breaks, these exercises will be conducted for 3 days a week for 6 weeks)

Pursed Lip Breathing Exercise

Other

Pursed lip breathing exercises will be performed by necessitating the subjects to inhale through their nose and then exhaling slowly for a period of 4-6 s by pursing the lips

Doming of the diaphragm

Other
  • The physiotherapist places the thumbs just inferior to the patient's lower costal margin and xiphoid process with the thumbs pointing cephalad.
  • The patient is instructed to take a deep breath and exhale. On exhalation, the physiotherapist's thumbs follow the diaphragm, which permits the thumbs to move posteriorly.
  • The patient is instructed to inhale, and the physiotherapist gently resists this motion.
  • The patient is instructed to exhale, and the physiotherapist gently follows this motion posteriorly and cephalad, as the thumbs are now beneath the costal margin and xiphoid process.
  • The patient inhales as the physiotherapist maintains pressure on the upper abdomen and then, on repeated exhalation, encourages further cephalad excursion.
  • This procedure is repeated for three to five respiratory cycles until the diaphragm domes easily at the end of exhalation.

Conventional exercise program for chronic neck pain

Other

Patients will perform three repetitions of stretching exercises for neck flexor, extensor, lateral flexor, and rotator for 30 seconds as warm-up and cool-down exercises, to relieve tension on each side of the neck.

Then cranio-cervical flexion exercise will be started using feedback from an air-filled pressure sensor placed behind the neck. Subjects will lay in the crook lying position. The pressure biofeedback unit will be placed below the occiput and inflated up to a baseline pressure of 20 mmHg. The subjects will be instructed to perform head-nodding action to progressively target 5 pressure levels (hold 10 seconds with brief rest periods between each contraction 3-5 seconds). This includes 3 sets in a session for 10 repetitions each with 2 minutes of rest between sets and 3days a week for 6 weeks.

Primary outcomes

  1. Endurance of deep cervical flexors

    Time frame: 6 weeks

    Endurance of deep cervical flexors muscles will be measured by the cranio-cervical flexion test using a pressure biofeedback instrument.

    During the cranio-cervical flexion test, the subject lay in the crook lying position and the pressure biofeedback instrument will be placed under the neutral cervical spine below the occiput and inflated up to 20 mmHg.

    The subjects will perform this movement at 5 different pressure levels, i.e., 22, 24, 26, 28, and 30 mmHg. Each level will be supposed to be held for 10 s, and the test will be terminated if they were unable to hold the position for 10 s at any level or if the maximum level was achieved (30 mmHg).

  2. Forced expiratory volume in the first second (FEV1)

    Time frame: 6 weeks

    Forced expiratory volume in the first second (FEV1) is one of ventilatory function test parameters, measured using Spirometry, Model SpirOx plus (by Meditech company-China)

    The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.

  3. Forced vital capacity (FVC).

    Time frame: 6 weeks

    Forced vital capacity (FVC) is one of pulmonary function test parameters, measured using Spirometry, Model SpirOx plus (by Meditech company-China)

    Forced vital capacity (FVC) is the volume of air that can forcefully expired from the lungs following maximum inspiration, it is measured in liters.

  4. Peak expiratory flow rate (PEFR)

    Time frame: 6 weeks

    Peak expiratory flow rate (PEFR) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration, measured in liters per second.

    Peak expiratory flow rate (PEFR) as a pulmonary function, is measured using Spirometry, Model SpirOx plus (by Meditech company-China)

  5. Neck Disability Index (NDI)

    Time frame: 6 weeks

    Neck function is assessed using the self-reported Neck Disability Index (NDI), which is a valid and reliable test for measuring neck disability. The NDI consists of 10 items referring to daily activities (work, lifting, driving, sleeping, reading, headaches, recreation, concentration, personal care, and pain intensity). Each item (ranging from 0 to 5, with a score of 0 for no pain and no limitation and a score of 5 for maximum pain and limitation). The total maximum score is 50.

  6. Visual Analogue Score for pain intensity

    Time frame: 6 weeks

    Visual Analogue score is a measure of pain severity, it is assessed by the self-reported Visual Analogue Scale (VAS).

    The Visual Analogue Scale evaluates the intensity of pain. It consists of a 10 cm line, that has two end points, where 0 represents "no pain at all" while 10 indicates "most severe pain".

    Every patient is asked to rate his/her level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain' (or zero) to the current pain mark.

    This provides pain intensity score out of 10.

Secondary outcomes

  1. FEV1/FVC ratio

    Time frame: 6 weeks

    FEV1/FVC ratio is a calculated ratio of Forced expiratory volume in the first second (FEV1) to Forced vital capacity (FVC).

    t represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).

Sponsors and collaborators

Lead sponsor

Mina Atef Georgui Elias

Other

Registry information

Official study title

Effect Of Diaphragmatic Doming Versus Breathing Exercises On Ventilatory Function And Core Endurance In Chronic Neck Pain Patients

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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